Anal incontinence treatment with wireless energy supply

ABSTRACT

An anal incontinence disease treatment apparatus and method include and use an operable restriction device implanted in a patient and engaging the colon or rectum to form a restricted. An energy transmission device for wireless transmission of energy of a first form from outside the patient&#39;s body is provided. An implanted energy transfer device transfers the energy of a first form transmitted by the energy transmission device into energy of a second form, which is used in connection with the operation of the restriction device, i.e. to open and close the fecal passageway.

CROSS REFERENCE TO RELATED APPLICATION

This application incorporates herein by reference the disclosure ofprovisional application Serial No. 60/148,345 filed Aug. 12, 1999.

BACKGROUND OF THE INVENTION

The present invention relates to an anal incontinence treatmentapparatus and method. More specifically, the invention relates to ananal incontinence treatment apparatus and method for surgicalapplication in the abdomen of a patient for forming a restricted fecalpassageway in the colon or rectum. The term “patient” includes an animalor a human being.

Anal incontinence is a wide-spread problem. Several kinds of sphincterplastic surgery are used today to remedy anal incontinence. There is aprior manually operated sphincter system in an initial clinical trialphase where a hydraulic sphincter system connected to an elasticreservoir (balloon) placed in the scrotum is developed. A disadvantageof this system is that thick, hard fibrosis is created around thereservoir by pump movements making the system useless sooner or later.

U.S. Pat. No. 5,593,443 discloses a hydraulic anal sphincter under bothreflex and voluntary control. A pressure controlled inflatableartificial sphincter is disclosed in U.S. Pat. No. 4,222,377.

SUMMARY OF THE INVENTION

The object of the present invention is to provide a new convenient analincontinence treatment apparatus and method, the performance of whichmay be affected by the patient at any time after operation, inparticular when need arise over the course of a day, so that the patientsubstantially always is satisfied or comfortable.

Accordingly, in accordance with a first main aspect of the inventionthere is provided an anal incontinence disease treatment apparatuscomprising an operable restriction device implanted in a patient andengaging the colon or rectum to form a restricted fecal passageway inthe colon or rectum, an energy transmission device for wirelesstransmission of energy of a first form from outside the patients body,and an energy transfer device implanted in the patient for transferringthe energy of the first form transmitted by the energy transmissiondevice into energy of a second form, which is used in connection withthe operation of the restriction device.

As a result, the advantage is achieved that the anal incontinencedisease treatment apparatus of the invention provides simple andeffective energy transmission which ensures long reliable function ofthe apparatus, possibly for the rest of the patient's life.

The restriction device preferably controls the cross-sectional area ofthe fecal passageway in the colon or rectum, which gives the advantagethat the patient is enabled to adjust the cross-sectional area of thefecal passageway, i.e. to open and close the fecal passageway, wheneverthe patient likes during the day. This advantage should not beunderestimated.

Advantageously, the implanted energy transfer device directly operatesthe restriction device with the energy of the second form, preferably ina non-magnetic and/or non-mechanical manner, as the external energytransmission device transmits the energy of the first form. Therestriction device may be directly operated with the energy of thesecond form without externally touching subcutaneously implantedcomponents of the apparatus. The advantage of directly using energy asit is transmitted is that the apparatus can be of a very simple designand the few components involved makes the apparatus extremely reliable.

The restriction device may be non-inflatable, i.e. with no hydraulicfluid involved for the adjustments of the restriction device. Thiseliminates problems with fluid leaking from the restriction device.

Preferably, the energy of the second form comprises electric energy. Inconsequence, the restriction device suitably is electrically operated,whereby the energy transfer device supplies electric energy for theoperation of the restriction device. The apparatus suitably comprisesimplanted electric conductors connected to the energy transfer device,whereby the energy transfer device is capable of supplying an electriccurrent, such as direct current, a pulsating direct current, acombination of a direct and pulsating direct current, an alternatingcurrent or a combination of a direct and alternating current, via theconductors. Furthermore, the electrical junction element may be capableof supplying a frequency, amplitude, or frequency and amplitudemodulated analog, digital, or a combination of analog and digitalsignal, which is used in connection with control of the restrictiondevice.

The energy transfer device, preferably in the form of an electricalsemiconductor junction element, suitably forms a flat and thin sheet andhas a volume of less than 2000 cm³ to be suited for subcutaneousimplantation, so that the electrical junction element is located justbehind the skin of the patient. The electrical junction element shouldbe designed to generate an output current exceeding 1 μA when exposed tothe energy of the first form transmitted by the energy transmissiondevice. Of course, all the components of the energy transfer deviceincluding the electrical junction element in contact with the patient'sbody should be of a biocompatible material. Alternatively, it would bepossible to implant the energy transfer device in the thorax or cephalregion of the patient, or in an orifice of the patient's body and underthe mucosa or intraluminar outside the mucosa of the orifice.

For in vitro appliances, a particular type of an electricalsemiconductor junction element has been commonly used, namely a socalled p-n (positive/negative) junction element, typically in the formof solar cells. A solar cell transfers solar energy in the form ofvisible light into electric energy in the form of direct current. Forexample, a p-n junction element may comprise two layers ofsemiconductor, one p-type (positive) and the other n-type (negative),sandwiched together to form a p-n junction. This p-n junction induces anelectric field across the element when absorbing quanta of light(photons).

To be more precise, the quanta of light transfer their energy to some ofthe semiconductor's electrons, which are then able to move about throughthe material. For each such negatively charged electron, a correspondingpositive charge—a hole—is created. In an ordinary semiconductor, theseelectrons and holes recombine after a short time and their energy iswasted as heat. However, when the electrons and holes are swept acrossthe p-n junction in opposite directions by the action of the electricfield, the separation of charge induces a voltage across the p-njunction element. By connecting the p-n junction element to an externalcircuit, the electrons are able to flow thereby creating a current.

Surprisingly, it has been proven that although both the skin andsubcutis absorb energy from an external light beam directed against theskin portion behind which a properly designed p-n junction element islocated, the light energy transmitted through the skin can induce acurrent from the p-n junction element strong enough (minimum 1 μA) toenable the operation of the electrically operated restriction device.Thus, such a p-n junction element is now for the first time used for invivo applications.

However, the apparatus of the present invention is not limited to theuse of visible light for the wireless transmission of energy. Thus, inaccordance with a broad aspect of the invention, the energy transmissiondevice transmits energy by at least one wireless signal, preferablycontaining radiant energy.

The wireless signal may comprises a wave signal, for example anelectromagnetic wave signal, such as an infrared light signal, a visiblelight signal, an ultra violet light signal,a laser signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal, and a gammaradiation signal. Where applicable, one or more of the above signals maybe combined. Alternatively, the wave signal may comprise a sound wavesignal, such as an ultrasonic signal. Generally, the wireless signal maycomprise a digital, analog or digital and analog signal.

The energy of the first form transmitted by the energy transmissiondevice may comprise an electric or magnetic field transmitted in pulses,for example digital pulses. Furthermore, the energy transfer device maytransfer the energy of the first form, which may comprise energy, into adirect current, pulsating direct current, a combination of a direct andpulsating direct current, an alternating current or a combination of adirect and alternating current. Alternatively, the energy of the firstform may comprise kinetic energy.

The energy of the second form may comprise a frequency, amplitude orfrequency and amplitude modulated analog, digital or combined analog anddigital signal.

In case the energy of the second form comprises electric energy, theapparatus may further comprise an implanted pulse generator forgenerating electrical pulses from the energy of the second form.

In accordance with a main embodiment of the invention, the apparatuscomprises an implanted operation device for operating the restrictiondevice and a control device for controlling the operation device,wherein the energy transfer device powers the operation device with theenergy of the second form. The operation device preferably comprises amotor, for example an electric linear motor or an electric rotary motorwhich is controlled by the control device to rotate a desired number ofrevolutions. The electric motor may have electrically conductive partsmade of plastics. Alternatively, the motor may comprise a hydraulic orpneumatic fluid motor, wherein the control device controls the fluidflow through the fluid motor. Motors currently available on the marketare getting smaller and smaller. Furthermore, there is a great varietyof control methods and miniaturized control equipment available. Forexample, a number of revolutions of a rotary motor may be analyzed by aHall-element just a few mm in size.

In accordance with another embodiment of the invention, the restrictiondevice comprises hydraulic means and the operation device comprises apump for pumping a fluid in the hydraulic means, a motor for driving thepump, a valveless fluid conduit between the pump and the hydraulic meansof the restriction device, and a reservoir for fluid, wherein thereservoir forms part of the conduit. All of the hydraulic componentsinvolved are preferably devoid of any non-return valve. This is of greatadvantage, because with valves involved there is always a risk ofmalfunction due to improperly working valves, especially when long timeperiods passes between valve operations. The reservoir may form a fluidchamber with a variable volume, and the pump may distribute fluid fromthe chamber to the hydraulic means of the restriction device byreduction of the volume of the chamber and withdraws fluid from thehydraulic means to the chamber by expansion of the volume of thechamber.

The energy of the second form may be, which enables the control deviceto reverse the operation device by shifting polarity of the energy ofthe second form. Where the operation device comprises an electric motorthe energy of the second form suitably comprises electric energy.

In accordance with yet another embodiment of the invention, therestriction device is operable to perform a reversible function, such asenlarging and restricting the fecal passageway, and there is a reversingdevice implanted in the patient for reversing the function performed bythe restriction device. Such a reversing function preferably involvesenlarging and restricting the fecal passageway by the restrictiondevice, suitably in a stepless manner. In this connection, the controldevice suitably controls the reversing device, which may include aswitch, to reverse the function performed by the restriction device. Thereversing device may comprise hydraulic means including a valve forshifting the flow direction of a fluid in the hydraulic means.Alternatively, the reversing device may comprise a mechanical reversingdevice, such as a switch or a gear box.

Where the reversing device comprises a switch it may be operable by theenergy of the second form. In this case, the control device suitablycontrols the operation of the switch by shifting polarity of energysupplied to the switch. The switch may comprise an electric switch andthe source of energy may supply electric energy for the operation of theswitch.

In accordance with a advantageous embodiment of the invention, theapparatus further comprises an energy storage device implanted in thepatient for storing the energy of the second form and for supplyingenergy in connection with the operation of the restriction device. Theimplanted energy storage device preferably comprises an electric sourceof energy, such as an accumulator, a rechargeable battery or acombination of an accumulator and rechargeable battery.

The apparatus may further comprise a switch implanted in the patient forswitching the operation of the restriction device and a source of energyimplanted in the patient. This embodiment is particularly suited forapplications where the energy transmission efficiency of the apparatusis insufficient, i.e. where the implanted restriction device is toperform more advanced operations. Such a source of energy preferably isa battery. Alternatively, the source of energy is an accumulator whichalso may store the energy of the second form.

In accordance with a first alternative, the switch is operated by theenergy of the second form supplied by the energy storage device toswitch from an off mode, in which the source of energy is not in use, toan on mode, in which the source of energy supplies energy for theoperation of the restriction device. In this case, the implanted sourceof energy may comprise a battery, preferably having a life-time of atleast 10 years, or an accumulator. However, other kinds of sources arealso conceivable, such as a nuclear source of energy or a chemicalsource of energy (fuel cells).

In accordance with a second alternative, the apparatus further comprisesa remote control for controlling the supply of energy of the implantedsource of energy, wherein the switch is operated by the energy of thesecond form supplied by the energy storage device to switch from an offmode, in which the remote control is prevented from controlling thesource of energy and the source of energy is not in use, to a standbymode, in which the remote control is permitted to control the source ofenergy to supply energy for the operation of the restriction device.

In accordance with a third alternative, the energy storage device isomitted, wherein the switch is operated by the energy of the second formsupplied by the energy transfer device to switch from an off mode, inwhich the remote control is prevented from controlling the source ofenergy and the source of energy is not in use, to a standby mode, inwhich the remote control is permitted to control the source of energy tosupply energy for the operation of the restriction device.

In accordance with a fourth alternative, also the remote control isomitted, wherein the switch is operated by the energy of the second formsupplied by the energy transfer device to switch from an off mode, inwhich the source of energy is not in use, to an on mode, in which thesource of energy supplies energy for the operation of the restrictiondevice. Where applicable, in the described embodiments the switch mayswitch when the energy transmission device is transmitting wirelessenergy, preferably while the transferred energy of the second form isstabilized by an implanted capacitor, which may temporarily (for a fewseconds) store the energy of the second form.

The switch mentioned above may comprise an electronic switch or, whereapplicable, a mechanical switch.

The advantage of using a switch above all is increased control safety,i.e. interfering signals in the patient's surroundings cannot affect theimplanted restriction device. Furthermore, the lifetime of the implantedsource of energy will be significantly prolonged, since the energyconsumption of the apparatus will be reduced to a minimum. During theabove mentioned standby mode, the remote control uses energy from theimplanted source of energy. By means of the energy transmission deviceenergy may be transmitted to activate the switch to connect theimplanted source of energy only when energy is required in connectionwith the operation of the restriction device.

All of the above embodiments may be combined with at least one implantedsensor for sensing at least one physical parameter of the patient,wherein the control device may control the restriction device inresponse to signals by the sensor. For example, the sensor may comprisea pressure sensor for directly or indirectly sensing the pressureagainst the restriction device, human tissue or in the fecal passageway.The pressure sensor may be any suitable known or conventional pressuresensor such as shown in U.S. Pat. Nos. 5,540,731, 4,846,181, 4,738,267,4,571,749, 4,407,296 or 3,939,823; or an NPC-102 Medical AngioplastySensor. The control device may comprise an internal control unitimplanted in the patient for, preferably directly, controlling therestriction device in response to signals from the sensor. In responseto signals from the sensor, for example pressure, the patient's positionor any other important physical parameter, the internal control unit maysend information thereon to outside the patient's body. The control unitmay also automatically control the restriction device in response tosignals from the sensor. For example, the control unit may control therestriction device to further restrict the fecal passageway in the colonor rectum in response to the sensor sensing that the patient is lying,or enlarge the fecal passageway in response to the sensor sensing anabnormally high pressure against the restriction device.

Alternatively, the control device may comprise an external control unitoutside the patient's body for, suitably directly, controlling therestriction device in response to signals by the sensor. The externalcontrol unit may store information on the physical parameter sensed bythe sensor and may be manually operated to control the restrictiondevice based on the stored information. In addition, there may be atleast one implanted sender for sending information on the physicalparameter sensed by the sensor.

An external data communicator may be provided outside the patient's bodyand an internal data communicator may be implanted in the patient forcommunicating with the external communicator. The implanted communicatormay feed data related to the patient, or related to the implantedrestriction device, back to the external communicator. Alternatively orin combination, the external communicator may feed data to the internalcommunicator. The implanted communicator may suitably feed data relatedto at least one physical signal of the patient.

The apparatus may further comprise an implanted programmable controlunit for controlling the restriction device, preferably over time inaccordance with an activity schedule program. This will advance theapparatus and make possible an adaptation of the apparatus to theindividual patients.

Many of the above embodiments are suitably remote controlled. Thus, theapparatus advantageously comprises a wireless remote controltransmitting at least one wireless control signal for controlling therestriction device. With such a remote control it will be possible toadapt the function of the apparatus to the patient's need in a dailybasis, which is beneficial with respect to the treatment of the patient.

The wireless remote control may be capable of obtaining information onthe condition of the implanted restriction device and of controlling therestriction device in response to the information. Also, the remotecontrol may be capable of sending information related to the restrictiondevice from inside the patient's body to the outside thereof.

In a particular embodiment of the invention, the wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver implanted in thepatient. In another particular embodiment of the invention, the wirelessremote control comprises at least one external signal receiver ortransceiver and at least one internal signal transmitter or transceiverimplanted in the patient.

The wireless remote control may transmit a carrier signal for carryingthe control signal, wherein the carrier signal is frequency, amplitudeor frequency and amplitude modulated and is digital, analog or digitaland analog. Also the control signal used with the carrier signal may befrequency, amplitude or frequency and amplitude modulated.

The control signal may comprise a wave signal, for example, a sound wavesignal, such as an ultrasound wave signal, an electromagnetic wavesignal, such as an infrared light signal, a visible light signal, anultra violet light signal, a laser signal, a micro wave signal, a radiowave signal, an x-ray radiation signal, or a gamma radiation signal.Where applicable, two or more of the above signals may be combined.

The control signal may be digital or analog, and may comprise anelectric or magnetic field. Suitably, the wireless remote control maytransmit an electromagnetic carrier wave signal for carrying the digitalor analog control signal. For example, use of an analog carrier wavesignal carrying a digital control signal would give safe communication.The control signal may be transmitted in pulses by the wireless remotecontrol.

The energy transfer device may be placed in the thorax, abdomen orcephalic region, or implanted subcutaneously.

The energy transfer device may comprise a p-n junction element,semiconductor circuitry, transistor circuitry or microchip.

The energy transmission device may function differently from or similarto the energy transfer device. For example, the energy transmission andtransfer devices function differently when the energy transmissiondevice comprises a coil used for transmitting the energy of the firstform and the energy transfer device comprises an electrical junctionelement for transferring the transmitted energy into the energy of thesecond form. The energy transmission and transfer devices functionsimilar to each other when the energy transmission device comprises acoil used for transmitting the energy of the first form and the energytransfer device also comprises a coil for transferring the transmittedenergy into the energy of the second form.

In accordance with a second main aspect of the invention there isprovided an anal incontinence disease treatment apparatus, comprising anoperable restriction device implanted in a patient and engaging thecolon or engaging the rectum to form a restricted fecal passageway inthe colon or rectum, an energy transmission device for wirelesstransmission of energy from outside the patient's body, and anactivatable source of energy implanted in the patient, wherein thesource of energy is activated by wireless energy transmitted by theenergy transmission device, to supply energy which is used in connectionwith the operation of the restriction device.

Where applicable, the above embodiments described in connection with thefirst main aspect of the invention may also be implemented in theapparatus related to the second main aspect of the invention.

Another object of the present invention is to provide a method forimplanting the anal incontinence disease apparatus of the invention.

Accordingly, there is provided an implanting method, comprising thesteps of providing an anal incontinence disease treatment apparatusaccording to the appended claim 1, cutting an opening in a patient'smucosa in an orifice of the patient's body, and implanting the energytransfer device in the patient's body through the opening.Alternatively, the cutting step may comprise cutting an opening in thepatient's skin and the implanting step may comprise implanting theenergy transfer device in the patient's body through the opening.

There is also provided a laparascopical implanting method, in accordancewith a first alternative, comprising the steps of providing an analincontinence disease treatment apparatus according to the appended claim1, placing at least two laparascopic cannula within a patient's body,and implanting the energy transfer device in the patient's body by usingthe at least two laparascopic cannula.

In accordance with a second alternative there is provided a laparoscopicsurgical method of implanting an anal incontinence disease treatmentapparatus, comprising the step of, a) placing at least two laparoscopictrocars within a patient's body, b) using at least one dissecting toolinserted through the laparoscopic trocar, dissecting the region of thecolon or rectum, c) introducing a restriction device of the apparatusthrough the trocars, and d) placing the restriction device in engagementwith the colon or rectum to create a restricted stoma.

The method may further comprise implanting an energy transfer device ofthe apparatus, for example subcutaneously, in the abdomen, thorax orcephal region, or other locations in the patient's body.

The method as recited in a)-d) further comprising postoperativelyadjusting the restricted stoma in a non-invasive procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 to 12 are schematic block diagrams illustrating twelveembodiments, respectively, of the anal incontinence disease treatmentapparatus of the invention, in which wireless energy is transmitted fromoutside a patient's body to energy consuming components of the apparatusimplanted in the patient.

FIG. 13 is a schematic block diagram illustrating conceivablecombinations of implanted components for achieving various communicationoptions;

FIG. 14 illustrates an electrical junction element for use in theapparatus of the present invention; and

FIG. 15 illustrates the apparatus in accordance with the inventionimplanted in a patient;

FIG. 16 is a block diagram illustrating remote control components of anembodiment of the invention, in which wireless energy is transmitted bythe use of electromagnetic signals; and

FIG. 17 is a schematic view of exemplary circuitry used for thecomponents of the block diagram of FIG. 16.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows a most simple embodiment of the analincontinence disease apparatus of the invention having some partsimplanted in a patient and other parts located outside the patient'sbody. Thus, in FIG. 1 all parts placed to the right of the patient'sskin 2 are implanted and all parts placed to the left of the skin 2 arelocated outside the patient's body.

The apparatus of FIG. 1 comprises an implanted operable restrictiondevice 4, which engages the patient's colon (or alternatively engagesthe rectum) to form a restricted fecal passageway in the rectum. Therestriction device 4 is capable of performing a reversible function,i.e. to enlarge and reduce the cross-sectional area of the fecalpassageway, whereby the restriction device 4 works as an artificialsphincter. An implanted energy transfer device 6 is adapted to supplyenergy consuming components of the restriction device 4 with energy viaa power supply line 12. An external energy transmission device 10includes a wireless remote control transmitting a wireless signal whichis received by a signal receiver incorporated in the implanted energytransfer device 6. The implanted energy transfer device 6 transfersenergy from the signal into electric energy which is supplied via thepower supply line 12.

FIG. 2 shows an embodiment of the invention identical to that of FIG. 1,except that a reversing device in the form of an electric switch 14operable by energy also is implanted in the patient for reversing therestriction device 4. The wireless remote control of the external energytransmission device 10 transmits a wireless signal that carries energyand the implanted energy transfer device 6 transfers the wireless energyinto a current for operating the switch 14. When the polarity of thecurrent is shifted by the energy transfer device 6 the switch 14reverses the function performed by the restriction device 4.

FIG. 3 shows an embodiment of the invention identical to that of FIG. 1,except that an operation device in the form of a motor 15 for operatingthe restriction device 4 also is implanted in the patient. The motor 15is powered with energy from the energy transfer device 6, as the remotecontrol of the external energy transmission device 10 transmits awireless signal to the receiver of the energy transfer device 6.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 1,except that an assembly 16 including a motor/pump unit 18 and a fluidreservoir 20 also is implanted in the patient. In this case therestriction device 4 is hydraulically operated, i.e. hydraulic fluid ispumped by the motor/pump unit 18 from the reservoir 20 through a conduit22 to the restriction device 4 to reduce the cross-sectional area of thefecal passageway, and hydraulic fluid is pumped by the motor/pump unit18 back from the restriction device 4 to the reservoir 20 to enlarge thecross-sectional area. The implanted energy transfer device unit 6transfers wireless energy into a current, for example a current, forpowering the motor/pump unit 18 via an electric power supply line 24.

FIG. 5 shows an embodiment of the invention comprising the externalenergy transmission device 10 with its wireless remote control, therestriction device 4, in this case hydraulically operated, and theimplanted energy transfer device 6, and further comprising an implantedhydraulic fluid reservoir 30, an implanted motor/pump unit 32 and animplanted reversing device in the form of a hydraulic valve shiftingdevice 34. The motor of the motor/pump unit 32 is an electric motor. Inresponse to a control signal from the wireless remote control of theexternal energy transmission device 10, the implanted energy transferdevice 6 powers the motor/pump unit 32 with energy from the energycarried by the control signal, whereby the motor/pump unit 32distributes hydraulic fluid between the reservoir 30 and the restrictiondevice 4. The remote control of the energy transmission device 10controls the shifting device 34 to shift the hydraulic fluid flowdirection between one direction in which the fluid is pumped by themotor/pump unit 32 from the reservoir 30 to the restriction device 4 toreduce the cross-sectional area of the fecal passageway, and anotheropposite direction in which the fluid is pumped by the motor/pump unit32 back from the restriction device 4 to the reservoir 30 to enlarge thecross-sectional area.

FIG. 6 shows an embodiment of the invention identical to that of FIG. 1,except that a control unit 36 controlled by the wireless remote controlof the external energy transmission device 10, an accumulator 38 and acapacitor 40 also are implanted in the patient. The control unit 36stores electric energy received from the energy transfer device 6 in theaccumulator 38, which supplies energy to the restriction device 4. Inresponse to a control signal from the wireless remote control of theenergy transmission device 10, the control unit 6 either releaseselectric energy from the accumulator 38 and transfers the releasedenergy via power lines 42 and 44, or directly transfers electric energyfrom the energy transfer device 6 via a power line 46, the capacitor 40,which stabilizes the electric current, a power line 48 and the powerline 44, for the operation of the restriction device 4.

In accordance with one alternative, the capacitor 40 in the embodimentof FIG. 6 may be omitted. In accordance with another alternative, theaccumulator 38 in this embodiment may be omitted.

FIG. 7 shows an embodiment of the invention identical to that of FIG. 1,except that a battery 50 for supplying energy for the operation of therestriction device 4 and an electric switch 52 for switching theoperation of the restriction device 4 also are implanted in the patient.The switch 52 is operated by the energy supplied by the energy transferdevice 6 to switch from an off mode, in which the battery 50 is not inuse, to an on mode, in which the battery 50 supplies energy for theoperation of the restriction device 4.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 7,except that a control unit 36 controllable by the wireless remotecontrol of the external energy transmission device 10 also is implantedin the patient. In this case, the switch 52 is operated by the energysupplied by the energy transfer device 6 to switch from an off mode, inwhich the wireless remote control is prevented from controlling thecontrol unit 36 and the battery is not in use, to a standby mode, inwhich the remote control is permitted to control the control unit 36 torelease electric energy from the battery 50 for the operation of therestriction device 4.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 8,except that an accumulator 38 is substituted for the battery 50 and theimplanted components are interconnected differently. In this case, theaccumulator 38 stores energy from the energy transfer device 6. Inresponse to a control signal from the wireless remote control of theexternal energy transmission device 10, the implanted control unit 36controls the switch 52 to switch from an off mode, in which theaccumulator 38 is not in use, to an on mode, in which the accumulator 38supplies energy for the operation of the restriction device 4.

FIG. 10 shows an embodiment of the invention identical to that of FIG.9, except that a battery 50 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the external energytransmission device 10, the implanted control unit 36 controls theaccumulator 38 to deliver energy for operating the switch 52 to switchfrom an off mode, in which the battery 50 is not in use, to an on mode,in which the battery 50 supplies electric energy for the operation ofthe restriction device 4.

Alternatively, the switch 52 may be operated by energy supplied by theaccumulator 38 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the battery 50 to supply electricenergy and is not in use, to a standby mode, in which the wirelessremote control is permitted to control the battery 50 to supply electricenergy for the operation of the restriction device 4.

FIG. 11 shows an embodiment of the invention identical to that of FIG.7, except that a motor 15, a mechanical reversing device in the form ofa gear box 54 and a control unit 36 for controlling the gear box 54 alsoare implanted in the patient. The implanted control unit 36 controls thegear box 54 to reverse the function performed by the restriction device4 (mechanically operated).

FIG. 12 shows an embodiment of the invention identical to that of FIG.10 except that the implanted components are interconnected differently.Thus, in this case the control unit 36 is powered by the battery 50 whenthe accumulator 38, suitably a capacitor, activates the switch 52 toswitch to an on mode. When the switch 52 is in its on mode the controlunit 36 is permitted to control the battery 50 to supply, or not supply,energy for the operation of the restriction device 4.

FIG. 13 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the implanted restriction device 4, control unit 36and motor/pump unit 18, and the external energy transmission device 10including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the implanted control unit 36, which in turn controls thevarious implanted components of the apparatus.

A sensor 56 may be implanted in the patient for sensing a physicalparameter of the patient, such as the pressure in the fecal passageway.The implanted control unit 36, or alternatively the external wirelessremote control of the energy transmission device 10, may control therestriction device 4 in response to signals from the sensor 56. Atranceiver may be combined with the sensor 56 for sending information onthe sensed physical parameter to the external wireless remote control.The wireless remote control may comprise a signal transmitter ortransceiver and the implanted control unit 36 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the implanted control unit36 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the restriction device 4 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 18 and battery 50 for powering the motor/pumpunit 18 are implanted, the battery 50 may be equipped with a tranceiverfor sending information on the condition of the battery 50.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 1-13 could be combined in many different ways. Forexample, the energy operated switch 14 could be incorporated in any ofthe embodiments of FIGS. 3,6-12, the hydraulic shifting device 34 couldbe incorporated in the embodiment of FIG. 4, and the gear box 54 couldbe incorporated in the embodiment of FIG. 3.

FIG. 14 shows an energy transfer device in the form of an electricaljunction element 58 for use in any of the above embodiments according toFIGS. 1-13. The element 58 is a flat p-n junction element comprising ap-type semiconductor layer 60 and an n-type semiconductor layer 62sandwiched together. A light bulb 64 is electrically connected toopposite sides of the element 58 to illustrate how the generated currentis obtained. The output of current from such a p-n junction element 58is correlated to the temperature. See the formula below.

I=IO(exp(qV/kT)−1)

where

I is the external current flow,

IO is the reverse saturation current,

q is the fundamental electronic charge of 1.602×10-19 coulombs,

V is the applied voltage,

k is the Boltzmann constant, and

T is the absolute temperature.

Under large negative applied voltage (reverse bias), the exponentialterm becomes negligible compared to 1.0, and I is approximately −IO. IOis strongly dependent on the temperature of the junction and hence onthe intrinsic-carrier concentration. 10 is larger for materials withsmaller bandgaps than for those with larger bandgaps. The rectifieraction of the diode—that is, its restriction of current flow to only onedirection—is in this particular embodiment the key to the operation ofthe p-n junction element 58.

An alternative way to design a p-n junction element is to deposit a thinlayer of semiconductor onto a supporting material which does not absorbthe kind of energy utilized in the respective embodiments. For use withwirelessly transmitted energy in terms of light waves, glass could be asuitable material. Various materials may be used in the semiconductorlayers such as but not limited to cadmium telluride,copper-indium-diselenide and silicon. It is also possible to use amultilayer structure with several layers of p and n-type materials toimprove efficiency.

The electric energy generated by the p-n junction element 58 could be ofthe same type as generated by solar cells, in which the negative andpositive fields create a direct current. Alternatively, the negative andpositive semiconductor layers may change polarity following thetransmitted waves, thereby generating an alternating current. The p-njunction element 58 is designed to make it suited for implantation.Thus, all the external surfaces of the element 58 in contact with thehuman body are made of a biocompatible material. The p-n junctionsemiconductors are designed to operate optimally at a body temperatureof 37° C. because the current output, which should be more than 1 μA, issignificantly depending on temperature as shown above. Since both theskin and subcutis absorb energy, the relation between the sensitivity orworking area of the element 58 and the intensity or strength of thewireless energy transmission is considered. The p-n junction element 58preferably is designed flat and small. Alternatively, if the element 58is made in larger sizes it should be flexible, in order to adapt to thepatient's body movements. The volume of the element 58 should be keptless than 2000 cm³.

FIG. 15 generally illustrates how any of the above-described embodimentsof the anal incontinence disease treatment apparatus of the inventionmay be implanted in a patient. Thus, a restriction device 4 implanted ina patient engages the colon 66 to form an artificial sphincter aroundthe fecal passageway in the colon. An implanted operation device 68,such as an electric motor or a motor/pump assembly, operates therestriction device 4 through a transmission member 70, such as amechanical transmission cord or a fluid tube. An energy transfer devicein the form of an element 6 having a positive region and a negativeregion, as described above in more detail, is placed underneath the skinof the patient.

Wireless energy carried by a signal transmitted by a wireless remotecontrol of an external energy transmission device 10 at least partlypenetrates the patient's skin and hits the element 6. The energy thushitting the element 6 is transferred into energy of a different formthat is suited for powering the operation device 68. For example, wherethe operation device 68 is an electric motor the element 6 comprises anelectric p-n junction element that transfers the wireless energy into anelectric current for powering the electric motor. Where the operationdevice 68 comprises a pump, the element 6 may transfer the wirelessenergy into kinetic energy for powering the pump.

The transferred energy may be utilized for directly operating therestriction device 4 or, where the restriction device 4 is electricallyoperated, for storage in a capacitor and/or an accumulator for later orparallel use. Preferably (but not necessarily) the element 6 iscontrolled by a microprocessor. The wireless remote control of theexternal energy transmission device 10 is used to control theutilization of the transmitted energy and any function or commandto/from the implanted restriction device 4.

FIG. 16 shows the basic parts of a wireless remote control of theapparatus of the invention including an electric motor 128 for operatinga restriction member, for example of the type illustrated in FIG. 15. Inthis case, the remote control is based on the transmission ofelectromagnetic wave signals, often of high frequencies in the order of100 kHz-1 gHz, through the skin 130 of the patient. In FIG. 15, allparts placed to the left of the skin 130 are located outside thepatient's body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 is to be positioned close toa signal receiving antenna 134 implanted close to the skin 130. As analternative, the receiving antenna 134 may be placed for example insidethe abdomen of the patient. The receiving antenna 134 comprises a coil,approximately 1-100 mm, preferably 25 mm in diameter, wound with a verythin wire and tuned with a capacitor to a specific high frequency. Asmall coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to either contractor enlarge the restriction device. The microprocessor starts a commandby applying a high frequency signal on the antenna 132. After a shorttime, when the signal has energized the implanted parts of the controlsystem, commands are sent to contract or enlarge the restriction devicein predefined steps. The commands are sent as digital packets in theform illustrated below.

Start pattern, 8 Command, 8 Count, 8 bits Checksum, 8 bits bits bits

The commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new contract or enlarge step isdesired the Count byte is increased by one to allow the implantedcontrol unit 138 to decode and understand that another step is demandedby the external control unit 136. If any part of the digital packet iserroneous, its content is simply ignored.

Through a line 140, an implanted energizer unit 126 draws energy fromthe high frequency electromagnetic wave signals received by thereceiving antenna 134. The energizer unit 126 stores the energy in anenergy storage device, such as a large capacitor, powers the controlunit 138 and powers the electric motor 128 via a line 142.

The control unit 138 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136. The microprocessor of the control unit 138 receives thedigital packet, decodes it and, provided that the power supply of theenergizer unit 126 has sufficient energy stored, sends a signal via asignal line 144 to the motor 128 to either contract or enlarge therestriction device depending on the received command code.

Alternatively, the energy stored in the energy storage device of theenergizer unit may only be used for powering a switch, and the energyfor powering the motor 128 may be obtained from another implanted energysource of relatively high capacity, for example a battery. In this casethe switch is adapted to connect said battery to the control unit 138 inan on mode when said switch is powered by the energy storage device andto keep the battery disconnected from the control unit in a standby modewhen the switch is unpowered.

With reference to FIG. 17, the remote control schematically describedabove will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of theapparatus. The power amplifier 150 amplifies the signals and sends themto the external signal transmitting antenna 132. The antenna 132 isconnected in parallel with a capacitor 152 to form a resonant circuittuned to the frequency generated by the signal generator 148.

The implanted signal receiving antenna coil 134 forms together with acapacitor 154 a resonant circuit that is tuned to the same frequency asthe transmitting antenna 132. The signal receiving antenna coil 134induces a current from the received high frequency electromagnetic wavesand a rectifying diode 160 rectifies the induced current, which chargesa storage capacitor 158. A coil 156 connected between the antenna coil134 and the diode 160 prevents the capacitor 158 and the diode 160 fromloading the circuit of the signal receiving antenna 134 at higherfrequencies. Thus, the coil 156 makes it possible to charge thecapacitor 158 and to transmit digital information using amplitudemodulation.

A capacitor 162 and a resistor 164 connected in parallel and a diode 166forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 168 connected in series with aresistor 170 connected in series with a capacitor 172 connected inseries with the resistor 168 via ground, and a capacitor 174, oneterminal of which is connected between the resistors 168,170 and theother terminal of which is connected between the diode 166 and thecircuit formed by the capacitor 162 and resistor 164. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 176 thatdecodes the digital information and controls the motor 128 via anH-bridge 178 comprising transistors 180,182,184 and 186. The motor 128can be driven in two opposite directions by the H-bridge 178.

The microprocessor 176 also monitors the amount of stored energy in thestorage capacitor 158. Before sending signals to activate the motor 128,the microprocessor 176 checks whether the energy stored in the storagecapacitor 158 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 176 waits for the receivedsignals to charge the storage capacitor 158 before activating the motor128.

In the practice of the present invention the details of the elongatedrestriction device 4 (such as a gastric band) and theadjustment/operation device (which may have electric, hydraulic, ormechanical, etc. actuation) 6, may be as described in copendingapplications Ser. No. 09/133,319, filed Aug. 13, 1998 (Atty Ref:2333-12), Ser. No. 09/133,320, filed Aug. 13, 1998 (Atty Ref: 2333-11)and Ser. No. 09/133,322, filed Aug. 13, 1998 (Atty Ref: 2333-13), thedisclosures of which are incorporated by reference herein.

The invention also comprises or consists of the foregoing structures andmethod steps, and is to be interpreted as broadly as allowed by theprior art.

What is claimed is:
 1. An anal incontinence disease treatment apparatus,comprising: an operable restriction device adapted to be implanted in apatient to engage the colon or rectum to form a restricted fecalpassageway in the colon or rectum, an energy transmission device forwireless transmission of energy of a first form from outside thepatient's body, an energy transfer device adapted to be implanted in thepatient for transferring energy of the first form transmitted by saidenergy transmission device into energy of a second form, different thanthe first form energy, said restriction device being operable inresponse to the second form energy to vary the restriction of therestricted fecal passageway, and an operation device adapted to beimplanted in the patient for operating said restriction device, whereinthe second form energy is used for powering said operation device tooperate said restriction device to close the fecal passageway to preventfeces to pass therethrough and to enlarge the fecal passageway to allowfeces to readily pass therethrough.
 2. The apparatus according to claim1, wherein said restriction device is electrically operated, and thesecond form energy comprises electric energy.
 3. The apparatus accordingto claim 2, further comprising electric conductors connected to saidenergy transfer device, whereby said energy transfer device is capableof supplying an electric current via said conductors.
 4. The apparatusaccording to claim 3, wherein said energy transfer device is capable ofsupplying a direct current, a pulsating direct current or a combinationof a direct current and pulsating direct current via said conductors. 5.The apparatus according to claim 2, wherein said energy transfer deviceis capable of generating a current exceeding 1 μA when transferring thefirst form energy transmitted by said energy transmission device.
 6. Theapparatus according to claim 3, wherein said energy transfer device iscapable of supplying an alternating current or a combination of a directand alternating current via said conductors.
 7. The apparatus accordingto claim 1, wherein said energy transfer device is capable of supplyinga frequency, amplitude or frequency and amplitude modulated signal. 8.The apparatus according to claim 1, wherein said energy transfer deviceis capable of supplying an analog, digital or a combination of an analogand digital signal.
 9. The apparatus according to claim 1, furthercomprising an implanted operation device for operating said restrictiondevice, wherein said energy transfer device powers said operation devicewith said energy of a second form.
 10. The apparatus according to claim9, wherein said operation device comprises a motor.
 11. The apparatusaccording to claim 10, further comprising a control device, wherein saidmotor comprises a rotary motor, and said control device controls saidrotary motor to rotate a desired number of revolutions.
 12. Theapparatus according to claim 10, wherein said motor comprises a linearmotor.
 13. The apparatus according to claim 10, further comprising acontrol device, wherein said motor comprises a hydraulic or pneumaticfluid motor, and said control device controls the said fluid motor. 14.The apparatus according to claim 10, wherein said motor comprises anelectric motor having electrically conductive parts made of plastics.15. The apparatus according to claim 9, wherein said restriction devicecomprises hydraulic means and said operation device comprises a pump forpumping a fluid in said hydraulic means.
 16. The apparatus according toclaim 15, wherein said operation device comprises a motor for drivingsaid pump.
 17. The apparatus according to claim 15, wherein saidoperation device comprises a fluid conduit between said pump and saidhydraulic means of said restriction device, and a reservoir for fluid,said reservoir forming part of said conduit.
 18. The apparatus accordingto claim 17, wherein said hydraulic means, pump and conduit is devoid ofany non-return valve.
 19. The apparatus according to claim 18, whereinsaid reservoir forms a fluid chamber with a variable volume, and saidpump distributes fluid from said chamber to said hydraulic means of saidrestriction device by reduction of the volume of said chamber andwithdraws fluid from said hydraulic means to said chamber by expansionof the volume of said chamber.
 20. The apparatus according to claim 9,further comprising a control device for controlling said operationdevice.
 21. The apparatus according to claim 20, wherein said controldevice shifts polarity of the second form energy to reverse saidoperation device.
 22. The apparatus according to claim 21, wherein saidoperation device comprises an electric motor and the second form energycomprises electric energy.
 23. The apparatus according to claim 20,wherein said restriction device is operable to perform a reversiblefunction.
 24. The apparatus according to claim 23, further comprising areversing device adapted to be implanted in the patient for reversingsaid function performed by said restriction device.
 25. The apparatusaccording to claim 24, wherein said control device controls saidreversing device to reverse said function by said restriction device.26. The apparatus according to claim 24, wherein said reversing devicecomprises hydraulic means including a valve for shifting the flowdirection of a fluid flow in said hydraulic means.
 27. The apparatusaccording to claim 24, wherein said reversing device comprises amechanical reversing device.
 28. The apparatus according to claim 27,wherein said reversing device comprises a gear box.
 29. The apparatusaccording to claim 24, wherein said reversing device comprises a switch.30. The apparatus according to claim 29, wherein the second form energycomprises electric energy and said switch is operable by the electricenergy.
 31. The apparatus according to claim 30, wherein said controldevice controls the operation of said switch by shifting polarity of theelectric energy.
 32. The apparatus according to claim 9, wherein saidoperation device comprises hydraulic means and at least one valve forcontrolling a fluid flow in said hydraulic means.
 33. The apparatusaccording to claim 32, further comprising a wireless remote control forcontrolling said valve.
 34. The apparatus according to claims 9, furthercomprising an operation device adapted to be implanted in the patientfor operating said restriction device.
 35. The apparatus according toclaim 34, wherein said operation device comprises a motor.
 36. Theapparatus according to claim 34, wherein said restriction devicecomprises hydraulic means and said operation device comprises a pump forpumping a fluid in said hydraulic means.
 37. The apparatus according toclaim 1, wherein said energy transfer device forms a flat and thinsheet, and has a volume of less than 2000 cm³.
 38. The apparatusaccording to claim 1, wherein said energy transfer device comprises atleast one semiconductor.
 39. The apparatus according to claim 1, furthercomprising an energy storage device adapted to be implanted in thepatient for storing the second form energy and for supplying energy foroperation of said restriction device.
 40. The apparatus according toclaim 35, wherein said energy storage device comprises an accumulator.41. The apparatus according to claim 40, wherein the second form energycomprises electric energy and said energy storage device comprises anelectric accumulator.
 42. The apparatus according to claim 41, whereinsaid electric accumulator comprises at least one capacitor or at leastone rechargeable battery.
 43. The apparatus according to claim 39,further comprising a switch adapted to be implanted in the patient fordirectly or indirectly switching the operation of said restrictiondevice.
 44. The apparatus according to claim 43, further comprising asource of energy adapted to be implanted in the patient, wherein saidswitch is operated by the second form energy supplied by said energystorage device to switch from an off mode, in which said source ofenergy is not in use, to an on mode, in which said source of energysupplies energy for the operation of said restriction device.
 45. Theapparatus according to claim 43, further comprising a source of energyadapted to be implanted in the patient, and a remote control forcontrolling the supply of energy of said source of energy, wherein saidswitch is operated by the second form energy supplied by said energystorage device to switch from an off mode, in which said remote controlis prevented from controlling said source of energy and said source ofenergy is not in use, to a standby mode, in which said remote control ispermitted to control said source of energy to supply energy for theoperation of said restriction device.
 46. The apparatus according toclaim 1, further comprising a switch adapted to be implanted in thepatient for switching the operation of said restriction device.
 47. Theapparatus according to claim 46, further comprising a source of energyadapted to be implanted in the patient for supplying energy for theoperation of said restriction device, wherein said switch is operated bythe second form energy supplied by said energy transfer device to switchfrom an off mode, in which said source of energy is not in use, to an onmode, in which said source of energy supplies energy for the operationof said restriction device.
 48. The apparatus according to claim 46,further comprising a source of energy adapted to be implanted in thepatient for supplying energy for the operation of said restrictiondevice, and a remote control for controlling the supply of energy ofsaid implanted source of energy, wherein said switch is operated by thesecond form energy supplied by said energy transfer device to switchfrom an off mode, in which said remote control is prevented fromcontrolling said source of energy and said source of energy is not inuse, to a standby mode, in which said remote control is permitted tocontrol said source of energy to supply energy for the operation of saidrestriction device.
 49. The apparatus according to claim 1, wherein saidenergy transmission device transmits the first form energy by at leastone wireless signal.
 50. The apparatus according to claim 49, whereinsaid signal comprises a wave signal.
 51. The apparatus according toclaim 50, wherein said wave signal comprises an electromagnetic wavesignal including one of an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal, and a gammaradiation signal.
 52. The apparatus according to claim 50, wherein saidwave signal comprises a sound wave signal.
 53. The apparatus accordingto claim 49, wherein said signal contains radiant energy.
 54. Theapparatus according to claim 49, wherein said signal comprises a digitalor analog signal, or a combination of a digital and analog signal. 55.The apparatus according to claim 1, wherein the first form energytransmitted by said energy transmission device comprises an electricfield.
 56. The apparatus according to claim 55, wherein said electricfield is transmitted in pulses or digital pulses, or a combination ofpulses and digital pulses by said energy transmission device.
 57. Theapparatus according to claim 1, wherein the first form energytransmitted by said energy transmission device comprises a magneticfield.
 58. The apparatus according to claims 57, wherein said magneticfield is transmitted in pulses or digital pulses, or a combination ofpulses and digital pulses by said energy transmission device.
 59. Theapparatus according to claim 1, wherein said energy transfer devicetransfers the first form energy into a direct current or pulsatingdirect current, or a combination of a direct current and a pulsatingdirect current.
 60. The apparatus according to claim 1, wherein saidenergy transfer device transfers the first form energy into analternating current or a combination of a direct and alternatingcurrent.
 61. The apparatus according to claim 1, wherein the second formenergy comprises a frequency or amplitude modulated signal, or acombination of a frequency and amplitude modulated signal.
 62. Theapparatus according to claim 1, wherein the second form energy comprisesan analog or a digital signal, or a combination of an analog and digitalsignal.
 63. The apparatus according to claim 1, further comprising apulse generator adapted to be implanted in the patient for generatingelectrical pulses from the second form energy.
 64. The apparatusaccording to claim 1, further comprising at least one sensor adapted tobe implanted in the patient for sensing at least one physical parameterof the patient.
 65. The apparatus according to claim 64, wherein saidsensor comprises a pressure sensor for directly or indirectly sensingthe pressure in said fecal passageway.
 66. The apparatus according toclaim 64, further comprising a control device for controlling saidrestriction device in response to signals from said sensor.
 67. Theapparatus according to claim 66, wherein said control device comprisesan internal control unit adapted to be implanted in the patient forcontrolling said restriction device in response to signals from saidsensor.
 68. The apparatus according to claim 66, wherein said internalcontrol unit directly controls said restriction device in response tosignals from said sensor.
 69. The apparatus according to claim 66,wherein said control device comprises an external control unit outsidethe patient's body for controlling said restriction device in responseto signals from said sensor.
 70. The apparatus according to claim 69,wherein said external control unit stores information on said physicalparameter sensed by said sensor and is manually operated to control saidrestriction device based on said stored information.
 71. The apparatusaccording to claim 64, further comprising at least one sender adapted tobe implanted in the patient for sending information on said physicalparameter sensed by said sensor.
 72. The apparatus according to claim 1,further comprising a wireless remote control transmitting at least onewireless control signal for controlling said restriction device.
 73. Theapparatus according to claim 72, wherein said remote control is capableof obtaining information on the condition of said restriction device andto control said restriction device in response to said information. 74.The apparatus according to claim 72, wherein said remote controlcomprises a control unit adapted to be implanted in the patient forcontrolling said restriction device.
 75. The apparatus according toclaim 74, wherein said control unit comprises a microprocessor.
 76. Theapparatus according to claim 72, wherein said wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver adapted to beimplanted in the patient.
 77. The apparatus according to claim 72,wherein said wireless remote control comprises at least one externalsignal receiver or transceiver and at least one internal signaltransmitter or transceiver adapted to be implanted in the patient. 78.The apparatus according to claim 72, wherein said remote control iscapable of sending information related to said restriction device frominside the patient's body to the outside thereof.
 79. The apparatusaccording to claim 78, wherein said remote control controls saidrestriction device in response to said information.
 80. The apparatusaccording to claim 72, wherein said remote control comprises a controlsignal transmitter for transmitting said control signal, and said energytransmission device comprises said control signal transmitter, wherebythe first form energy is transmitted by said control signal.
 81. Theapparatus according to claim 72, wherein said energy transmission devicetransmits the first form energy by at least one signal separate fromsaid control signal.
 82. The apparatus according to claim 72, whereinsaid remote control transmits a carrier signal for carrying said controlsignal.
 83. The apparatus according to claim 72, wherein said energytransmission device transmits the first form energy by at least onesignal, which is used as a carrier signal for said control signaltransmitted by said remote control.
 84. The apparatus according to claim83, wherein said carrier signal is frequency, amplitude or frequency andamplitude modulated.
 85. The apparatus according to claim 83, whereinsaid carrier signal comprises digital, analog or a combination ofdigital and analog waves.
 86. The apparatus according to claim 83,wherein said control signal used with said carrier signal is frequency,amplitude or frequency and amplitude modulated.
 87. The apparatusaccording to claim 83, wherein said control signal used with saidcarrier signal is digital, analog or combined digital and analog. 88.The apparatus according to claim 72, wherein said control signalcomprises a wave signal comprising one of a sound wave signal includingan ultrasound wave signal, an electromagnetic wave signal including aninfrared light signal, a visible light signal, an ultra violet lightsignal and a laser light signal, a micro wave signal, a radio wavesignal, an x-ray radiation signal, and a gamma radiation signal.
 89. Theapparatus according to claim 72, wherein said control signal comprisesan electric or magnetic field, or a combined electric and magneticfield.
 90. The apparatus according to claim 72, wherein said controlsignal comprises a digital, analog or combined digital and analogcontrol signal.
 91. The apparatus according to claim 90, wherein saidremote control transmits an electromagnetic carrier wave signal forcarrying said digital or analog control signal.
 92. The apparatusaccording to claim 1, wherein the second form energy second form usedfor operating said restriction device is wirelessly transmitted by saidenergy transfer device.
 93. The apparatus according to claim 1, furthercomprising a control unit adapted to be implanted in the patient forcontrolling said restriction device.
 94. The apparatus according toclaim 93, wherein said control unit is programmable for controlling saidrestriction device in accordance with a program.
 95. The apparatusaccording to claim 94, wherein said control unit controls saidrestriction device over time in accordance with an activity scheduleprogram.
 96. The apparatus according to claim 94, further comprising anexternal wireless remote control for programming said control unit. 97.The apparatus according to claim 1, further comprising an external datacommunicator and a data communicator adapted to be implanted in thepatient for communicating with said external communicator, wherein saidimplantable data communicator feeds data related to said restrictiondevice back to said external communicator or said external communicatorfeeds data to said implantable data communicator.
 98. The apparatusaccording to claim 97, wherein said implantable data communicator feedsdata related to at least one physical signal of the patient.
 99. Theapparatus according to claim 1, wherein said restriction device controlsthe cross-sectional area of the fecal passageway.
 100. The apparatusaccording to claim 1, wherein said restriction device is noninflatable.101. The apparatus according to claim 1, wherein one of the first formenergy and the second form energy energy comprises magnetic energy. 102.The apparatus according to claim 1, wherein one of the first form energyand the second form energy comprises kinetic energy.
 103. The apparatusaccording to claim 1, wherein one of the first form energy and thesecond form energy comprises sound energy.
 104. The apparatus accordingto claim 1, wherein the second form energy comprises chemical energy.105. The apparatus according to claim 1, wherein one of the first formenergy and the second form energy comprises radiant energy.
 106. Theapparatus according to claim 1, wherein one of the first form energy andthe second form energy comprises electromagnetic energy.
 107. Theapparatus according to claim 1, wherein one of the first form energy andthe second form energy comprises photo energy.
 108. The apparatusaccording to claim 1, wherein one of the first form energy and thesecond form energy comprises nuclear energy.
 109. The apparatusaccording to claim 1, wherein one of the first form energy and thesecond form energy comprises thermal energy.
 110. The apparatusaccording to claim 1, wherein one of the first form energy and thesecond form energy is non-magnetic.
 111. The apparatus according toclaim 1, wherein one of the first form energy and the second form energyis non-kinetic.
 112. The apparatus according to claim 1, wherein one ofthe first form energy and the second form energy is non-chemical. 113.The apparatus according to claim 1, wherein one of the first form energyand the second form energy is non-sonic.
 114. The apparatus according toclaim 1, wherein one of the first form energy and the second form energyis non-nuclear.
 115. The apparatus according to claim 1, wherein one ofthe first form energy and the second form energy is non-thermal. 116.The apparatus according to claim 1, further comprising a stabilizeradapted to be implanted in the patient for stabilizing the second formenergy.
 117. The apparatus according to claim 116, wherein said energyof a second form comprises electric current and said stabilizercomprises a capacitor.
 118. The apparatus according to claim 1, whereinsaid energy transmission device functions differently from said energytransfer device.
 119. The apparatus according to claim 1, wherein saidenergy transmission device functions similar to said energy transferdevice.
 120. The apparatus according to claim 1, wherein saidrestriction device is directly operated with the second form energy, assaid energy transmission device transmits the first form energy . 121.The apparatus according to claim 120, wherein said energy transferdevice directly operates said restriction device with the second formenergy in a non-magnetic manner.
 122. The apparatus according to claim120, wherein said energy transfer device directly operates saidrestriction device with the second form energy in a non-mechanicalmanner.
 123. The apparatus according to claim 1, wherein said energytransfer device is adapted to be implanted subcutaneously or in theabdomen of the patient.
 124. The apparatus according to claim 1, whereinsaid energy transfer device is adapted to be implanted in the thorax orin the cephalic region of the patient.
 125. The apparatus according toclaim 1, wherein said energy transfer device is adapted to be implantedin an orifice of the patient's body and under the mucosa or intraluminaroutside the mucosa of the orifice.
 126. An anal incontinence diseasetreatment apparatus, comprising: an operable restriction device adaptedto be implanted in a patient to engage the colon or rectum to form arestricted fecal passageway in the colon or rectum, an energytransmission device for wireless transmission of energy from outside thepatient's body, and an activatable source of energy adapted to beimplanted in the patient, wherein said source of energy is activated bywireless energy transmitted by said energy transmission device, tosupply energy which is used for operating said restriction device toclose the fecal passageway to prevent feces to pass therethrough and toenlarge the fecal passageway to allow feces to readily passtherethrough.
 127. An implanting method, comprising the steps of:providing an anal incontinence disease treatment apparatus according toclaim 1, cutting an opening in a patient's mucosa in an orifice of thepatient's body, and implanting the energy transfer device in thepatient's body through the opening.
 128. An implanting method,comprising the steps of: providing an anal incontinence diseasetreatment apparatus according to claim 1, cutting an opening in apatient's skin, and implanting the energy transfer device in thepatient's body through the opening.
 129. A laparascopical implantingmethod, comprising the steps of: providing an anal incontinence diseasetreatment apparatus according to claim 1, placing at least twolaparascopic cannula within a patient's body, and implanting the energytransfer device in the patient's body by using the at least twolaparascopic cannula.
 130. A laparoscopic surgical method of implantingin a patient an anal incontinence disease treatment apparatus,comprising the steps of: a) placing at least two laparoscopic trocarswithin the patient's body, b) using a dissecting tool inserted throughthe laparoscopic trocars, dissecting the region of the colon or rectum,c) introducing an operable restriction device of the apparatus throughthe trocars, d) placing the restriction device in engagement with therectum or colon to create a restricted stoma therein, e) implanting inthe patient an energy transfer device of the apparatus, f) transferringby the energy transfer device wireless energy of a first form intoenergy of a second form different than the first form energy, and g)operating the restriction device with the second form energy to closethe stoma to prevent feces to pass therethrough and to enlarge the stomato allow feces to readily pass therethrough.
 131. An anal incontinencedisease treatment apparatus, comprising: an operable restriction deviceadapted to be implanted in a patient to engage the colon or rectum toform a restricted fecal passageway in the colon or rectum, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body, an energy transfer device adapted to beimplanted in the patient for transferring energy of the first formtransmitted by said energy transmission device into energy of a secondform, different than the first form energy, said restriction devicebeing operable in response to the second form energy to vary therestriction of the restricted fecal passageway, a wireless remotecontrol transmitting at least one wireless control signal forcontrolling said restriction device, wherein said remote controlcomprises a control signal transmitter for transmitting said controlsignal and said energy transmission device comprises said control signaltransmitter, whereby the first form energy is transmitted by saidcontrol signal.
 132. The apparatus according to claim 131, wherein saidcontrol signal comprises a wave signal.
 133. The apparatus according toclaim 132, wherein said wave signal comprises an electromagnetic wavesignal including one of an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal, and a gammaradiation signal.
 134. The apparatus according to claim 132, whereinsaid wave signal comprises a sound wave signal.
 135. The apparatusaccording to claim 131, wherein said control signal comprises a digitalor analog signal, or a combination of a digital and analog signal. 136.The apparatus according to claim 131, wherein the first form energytransmitted by said energy transmission device comprises an electricfield.
 137. The apparatus according to claim 131, wherein the first formenergy transmitted by said energy transmission device comprises amagnetic field.
 138. The apparatus according to claim 137, wherein saidmagnetic field is transmitted in pulses or digital pulses, or acombination of pulses and digital pulses by said energy transmissiondevice.
 139. The apparatus according to claim 131, further comprising atleast one sensor adapted to be implanted in the patient for sensing atleast one physical parameter of the patient.
 140. The apparatusaccording to claim 139, further comprising a control device forcontrolling said restriction device in response to signals from saidsensor.
 141. An anal incontinence disease treatment apparatus,comprising: an operable restriction device adapted to be implanted in apatient to engage the colon or rectum to form a restricted fecalpassageway in the colon or rectum, an energy transmission device forwireless transmission of energy of a first form from outside thepatient's body, an energy transfer device adapted to be implanted in thepatient for transferring energy of the first form transmitted by saidenergy transmission device into energy of a second form, different thanthe first form energy, said restriction device being operable inresponse to the second form energy to vary the restriction of therestricted fecal passageway, and a wireless remote control transmittingat least one wireless control signal for controlling said restrictiondevice, wherein said energy transmission device transmits the first formenergy by at least one signal, which is used as a carrier signal forsaid control signal transmitted by said remote control.
 142. Theapparatus according to claim 141, wherein said carrier signal isfrequency, amplitude or frequency and amplitude modulated.
 143. Theapparatus according to claim 141, wherein said carrier signal comprisesdigital, analog or a combination of digital and analog waves.
 144. Theapparatus according to claim 141, wherein said control signal used withsaid carrier signal is frequency, amplitude or frequency and amplitudemodulated.
 145. The apparatus according to claim 141, wherein saidcontrol signal used with said carrier signal is digital, analog orcombined digital and analog.
 146. The apparatus according to claim 141,wherein said signal comprises a wave signal.
 147. The apparatusaccording to claim 146, wherein said wave signal comprises anelectromagnetic wave signal including one of an infrared light signal, avisible light signal, an ultra violet light signal, a laser signal, amicro wave signal, a radio wave signal, an x-ray radiation signal, and agamma radiation signal.
 148. The apparatus according to claim 141,wherein the first form energy transmitted by said energy transmissiondevice comprises an electric field.
 149. The apparatus according toclaim 141, further comprising at least one sensor adapted to beimplanted in the patient for sensing at least one physical parameter ofthe patient.
 150. The apparatus according to claim 149, furthercomprising a control device for controlling said restriction device inresponse to signals from said sensor.
 151. An anal incontinence diseasetreatment apparatus, comprising: an operable restriction device adaptedto be implanted in a patient to engage the colon or rectum to form arestricted fecal passageway in the colon or rectum, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body, an energy transfer device adapted to beimplanted in the patient for transferring energy of the first formtransmitted by said energy transmission device into energy of a secondform, different than the first form energy, an energy storage deviceadapted to be implanted in the patient for storing the second formenergy and for supplying energy for operation of said restrictiondevice, and a switch adapted to be implanted in the patient for directlyor indirectly switching the supply of energy from said energy storagedevice, wherein said switch is inoperable by permanent magnets.
 152. Theapparatus according to claim 151, wherein said restriction device isoperable to perform a reversible function.
 153. The apparatus accordingto claim 152, further comprising a reversing device adapted to beimplanted in the patient for reversing said function performed by saidrestriction device.
 154. The apparatus according to claim 153, whereinsaid reversing device comprises a switch.
 155. The apparatus accordingto claim 151, further comprising a stabilizer adapted to be implanted inthe patient for stabilizing the energy of the second form.
 156. Theapparatus according to claim 155, wherein said energy of a second formcomprises electric current and said stabilizer comprises a capacitor.157. An anal incontinence disease treatment apparatus, comprising: anoperable restriction device adapted to be implanted in a patient toengage the colon or rectum to form a restricted fecal passageway in thecolon or rectum, an energy transmission device for wireless transmissionof energy of a first form from outside the patient's body, an energytransfer device adapted to be implanted in the patient for transferringenergy of the first form transmitted by said energy transmission deviceinto energy of a second form, different than the first form energy, anenergy storage device adapted to be implanted in the patient for storingthe second form energy and for supplying energy for operation of saidrestriction device, a switch adapted to be implanted in the patient fordirectly or indirectly switching the supply of energy from said energystorage device, and a source of energy adapted to be implanted in thepatient, wherein said switch is operable by the second form energysupplied by said energy storage device to switch from an off mode, inwhich said source of energy is not in use, to an on mode, in which saidsource of energy supplies energy for the operation of said restrictiondevice.
 158. An anal incontinence disease treatment apparatus,comprising: an operable restriction device adapted to be implanted in apatient to engage the colon or rectum to form a restricted fecalpassageway in the colon or rectum, an energy transmission device forwireless transmission of energy of a first form from outside thepatient's body, an energy transfer device adapted to be implanted in thepatient for transferring energy of the first form transmitted by saidenergy transmission device into energy of a second form, different thanthe first form energy, an energy storage device adapted to be implantedin the patient for storing the second form energy and for supplyingenergy for operation of said restriction device, a switch adapted to beimplanted in the patient for directly or indirectly switching the supplyof energy from said energy storage device, a source of energy adapted tobe implanted in the patient, and a remote control for controlling thesupply of energy of said source of energy, wherein said switch isoperated by the second form energy supplied by said energy storagedevice to switch from an off mode, in which said remote control isprevented from controlling said source of energy and said source ofenergy is not in use, to a standby mode, in which said remote control ispermitted to control said source of energy to supply energy for theoperation of said restriction device.
 159. An anal incontinence diseasetreatment apparatus, comprising: an operable restriction device adaptedto be implanted in a patient to engage the colon or rectum to form arestricted fecal passageway in the colon or rectum, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body, an energy transfer device adapted to beimplanted in the patient for transferring energy of the first formtransmitted by said energy transmission device into energy of a secondform, different than the first form energy, and an energy storage deviceadapted to be implanted in the patient for storing the second formenergy and for supplying energy for operation of said restrictiondevice.
 160. The apparatus according to claim 159, wherein the secondform energy comprises electric energy and said energy storage devicecomprises at least one rechargeable battery.
 161. The apparatusaccording to claim 159, wherein said restriction device is operable toperform a reversible function.
 162. The apparatus according to claim161, further comprising a reversing device adapted to be implanted inthe patient for reversing said function performed by said restrictiondevice.
 163. The apparatus according to claim 161, further comprising acontrol device for controlling said reversing device to reverse saidfunction performed by said restriction device.
 164. The apparatusaccording to claim 159, wherein the energy of the second form compriseselectric energy.
 165. The apparatus according to claim 159, wherein oneof the first form energy and the second form energy is non-thermal. 166.The apparatus according to claim 159, wherein said restriction device isdirectly operated with the second form energy, as said energytransmission device transmits the first form energy.
 167. The apparatusaccording to claim 159, herein said energy transfer device directlyoperates said restriction device with the second form energy in anon-magnetic manner.
 168. The apparatus according to claim 159, whereinone of the first form energy and the second form energy comprises soundenergy.
 169. The apparatus according to claim 159, wherein one of thefirst form energy and the second form energy comprises photo energy.170. The apparatus according to claim 159, further comprising astabilizer adapted to be implanted in the patient for stabilizing theenergy of the second form.
 171. The apparatus according to claim 170,wherein said energy of a second form comprises electric current and saidstabilizer comprises a capacitor.
 172. The apparatus according to claim159, further comprising at least one sensor adapted to be implanted inthe patient for sensing at least one physical parameter of the patient.173. The apparatus according to claim 159, wherein the first form energytransmitted by said energy transmission device comprises an electricfield.
 174. The apparatus according to claim 159, wherein the first formenergy transmitted by said energy transmission device comprises amagnetic field.
 175. The apparatus according to claim 159, wherein saidenergy transfer device transfers the first form energy into a directcurrent or pulsating direct current, or a combination of a directcurrent and a pulsating direct current.
 176. The apparatus according toclaim 159, wherein said energy transfer device transfers the first formenergy into an alternating current or a combination of a direct andalternating current.
 177. The apparatus according to claim 159, whereinsaid energy storage device comprises an accumulator.
 178. The apparatusaccording to claim 159, wherein said energy of a second form compriseselectric energy and said energy storage device comprises an electricaccumulator.
 179. The apparatus according to claim 159, wherein saidremote control comprises an implanted control unit for controlling saidrestriction device.
 180. The apparatus according to claim 179, whereinsaid control unit comprises a microprocessor.
 181. An anal incontinencedisease treatment apparatus, comprising: an operable restriction deviceadapted to be implanted in a patient to engage the colon or rectum toform a restricted fecal passageway in the colon or rectum, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body, an energy transfer device adapted to beimplanted in the patient for transferring energy of the first formtransmitted by said energy transmission device into energy of a secondform, different than the first form energy, a switch adapted to beimplanted in the patient for switching the operation of said restrictiondevice, and a source of energy adapted to be implanted in the patientfor supplying energy for the operation of said restriction device,wherein said switch is operable by the second form energy supplied bysaid energy transfer device to switch from an off mode, in which saidsource of energy is not in use, to an on mode, in which said source ofenergy supplies energy for the operation of said restriction device.182. The apparatus according to claim 181, further comprising astabilizer adapted to be implanted in the patient for stabilizing theenergy of the second form.
 183. The apparatus according to claim 182,wherein the energy of the second form comprises electric current andsaid stabilizer comprises a capacitor.
 184. An anal incontinence diseasetreatment apparatus, comprising: an operable restriction device adaptedto be implanted in a patient to engage the colon or rectum to form arestricted fecal passageway in the colon or rectum, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body, an energy transfer device adapted to beimplanted in the patient for transferring energy of the first formtransmitted by said energy transmission device into energy of a secondform, different than the first form energy, a switch adapted to beimplanted in the patient for switching the operation of said restrictiondevice, a source of energy adapted to be implanted in the patient forsupplying energy for the operation of said restriction device, and aremote control for controlling the supply of energy of said source ofenergy, wherein said switch is operable by the second form energysupplied by said energy transfer device to switch from an off mode, inwhich said remote control is prevented from controlling said source ofenergy and said source of energy is not in use, to a standby mode, inwhich said remote control is permitted to control said source of energyto supply energy for the operation of said restriction device.
 185. Ananal incontinence disease treatment apparatus, comprising: an operablerestriction device adapted to be implanted in a patient to engage thecolon or rectum to form a restricted fecal passageway in the colon orrectum, an energy transmission device for wireless transmission ofenergy of a first form from outside the patient's body, an energytransfer device adapted to be implanted in the patient for transferringenergy of the first form transmitted by said energy transmission deviceinto energy of a second form, different than the first form energy,wherein said restriction device is adapted to be directly operated tovary the restriction of the restricted fecal passageway, in response tothe second form energy transferred by said energy transfer device, assaid energy transmission device transmits the first form energy. 186.The apparatus according to claim 185, wherein said operation devicecomprises a motor.
 187. The apparatus according to claim 185, whereinsaid restriction device comprises hydraulic means and said operationdevice comprises a pump for pumping a fluid in said hydraulic means.188. The apparatus according to claim 185, wherein said restrictiondevice is operable to perform a reversible function.
 189. The apparatusaccording to claim 188, further comprising a reversing device adapted tobe implanted in the patient for reversing said function performed bysaid restriction device.
 190. The apparatus according to claim 189,wherein said reversing device comprises a switch.
 191. The apparatusaccording to claim 185, further comprising a stabilizer adapted to beimplanted in the patient for stabilizing the second form energy. 192.The apparatus according to claim 191, wherein the energy of the secondform comprises electric current and said stabilizer comprises acapacitor.
 193. The apparatus according to claim 185, wherein the energyof the second form comprises electric energy.
 194. A surgical method ofimplanting in a patient an anal incontinence disease treatmentapparatus, comprising the steps of: a) dissecting the region of thecolon or rectum, b) implanting an operable restriction device inengagement with the rectum or colon to create a restricted stomatherein, c) implanting an energy transfer device of the apparatus, d)transferring by the energy transfer device wireless energy of a firstform into energy of a second form different than the first form energy,and e) operating the restriction device with the second form energy toclose the stoma to prevent feces to pass therethrough and to enlarge thestoma to allow feces to readily pass therethrough.